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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7262-004 | Other Identifier | MSD | |
| U1111-1333-1832 | Registry Identifier | UTN | |
| 2025-525102-38-00 | Registry Identifier | EU CT |
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Researchers designed a trial medicine called MK-7262 to lower levels of Lp(a) in the blood. Researchers want to learn about giving MK-7262 with another trial medicine called enlicitide (also known as MK-0616 or enlicitide decanoate). Enlicitide is in a group of medicines that lower the amount of low-density lipoprotein cholesterol (LDL-C).
The goals of this trial are to evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive MK-7262 placebo + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
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| enlicitide monotherapy | Active Comparator | Participants will receive enlicitide + MK-7262 placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
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| MK-7262 monotherapy | Experimental | Participants will receive MK-7262 + enlicitide placebo orally once daily (QD) for up to approximately 12 weeks of treatment. |
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| MK-7262 + enlicitide | Experimental | Participants will receive MK-7262 + enlicitide orally once daily (QD) for up to approximately 12 weeks of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7262 | Drug | Oral Coated Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Lipoprotein (a) (Lp(a)) at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change from baseline in Lp(a). | Baseline and Week 8 |
| Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C. | Baseline and Week 8 |
| Number of Participants who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to approximately 20 Weeks |
| Number of Participants Who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in LDL-C at Week 8 (enlicitide monotherapy vs. placebo) | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with enlicitide monotherapy versus placebo. | Baseline and Week 8 |
| Percent Change from Baseline in LDL-C at Week 8 (MK-7262 monotherapy vs. placebo) |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@merck.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMR Clinical Mobile ( Site 0149) | Recruiting | Mobile | Alabama | 36608 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Enlicitide | Drug | Oral Coated Tablet |
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| Placebo for MK-7262 | Drug | Oral Coated Tablet |
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| Placebo for enlicitide | Drug | Oral Coated Tablet |
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Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 monotherapy versus placebo. |
| Baseline and Week 8 |
| Percent Change from Baseline in Lp(a) at Week 8 (MK-7262 + enlicitide vs. MK-7262 monotherapy) | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in Lp(a) between participants treated with MK-7262 + enlicitide versus MK-7262 monotherapy. | Baseline and Week 8 |
| Percent Change from Baseline in LDL-C at Week 8 (MK-7262 + enlicitide vs. enlicitide monotherapy) | Blood samples will be collected at baseline and at Week 8 to assess the mean percent change in LDL-C between participants treated with MK-7262 + enlicitide versus enlicitide monotherapy. | Baseline and Week 8 |
| Percentage of Participants with Lp(a) <125 nmol/L at Week 8 | Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <125 nmol/L. The percentage of participants with Lp(a) <125 nmol/L at week 8 will be reported. | Week 8 |
| Percentage of Participants with Lp(a) <75 nmol/L at Week 8 | Blood samples will be collected at Week 8 to assess the percentage of participants who have Lp(a) <75 nmol/L. The percentage of participants with Lp(a) <75 nmol/L at week 8 will be reported. | Week 8 |
| Percent Change from Baseline in Lp(a) at Week 12 | Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in Lp(a). | Baseline and Week 12 |
| Percent Change from Baseline in LDL-C at Week 12 | Blood samples will be collected at baseline and at Week 12 to assess the mean percent change from baseline in LDL-C. | Baseline and Week 12 |
| Clinical Trials Research ( Site 0127) | Recruiting | Lincoln | California | 95648 | United States |
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| Chase Medical Research, LLC ( Site 0163) | Recruiting | Waterbury | Connecticut | 06708 | United States |
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| Inpatient Research Clinic ( Site 0110) | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Clinical Research Trials of Florida ( Site 0101) | Recruiting | Tampa | Florida | 33607 | United States |
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| Conquest Research LLC ( Site 0140) | Recruiting | Winter Park | Florida | 32789 | United States |
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| New Mexico Clinical Research & Osteoporosis Center ( Site 0119) | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| Holston Medical Group ( Site 0117) | Recruiting | Kingsport | Tennessee | 37660 | United States |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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